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Clinical Trials in the USA / NCT04457154
Recruiting Observational

Pediatric Post-Approval Registry

NCT04457154 · tracked via the Priya Life Science USA tracker
Sponsor
Inspire Medical Systems, Inc.
Phase
Observational
Started
2021-11-30
Last updated
2025-02-25

Condition(s) studied

Obstructive Sleep Apnea

Investigational drug(s) / intervention(s)

Inspire Upper Airway Stimulation System

Inspire Upper Airway Stimulation System: Implant of the Inspire Upper Airway Stimulation System

Study summary

This registry is a prospective, multi-center, single-arm study of pediatric subjects (ages 18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) System for the treatment of moderate or severe obstructive sleep apnea (OSA). Implanted subjects will be followed for 5 years post-implant.

Eligibility

Sex
ALL
Min age
18 Years
Max age
21 Years
Healthy volunteers
No
Inclusion Criteria: 1. Subject is between 18 and 21 years of age; 2. Subject has a diagnosis of moderate to severe OSA (15 ≤ AHI ≤ 65) based on a recent sleep study; 3. Subject has documented failure of, or intolerance to, positive airway pressure treatments, despite attempts to improve compliance; 4. Subject is contraindicated for, or not effectively treated by, adenotonsillectomy; 5. Subject has followed standard of care in considering all other alternative/adjunct therapies; 6. Subject is willing and able to have stimulation hardware permanently implanted and to use the patient remote to activate the stimulation; 7. Subject is willing and able to return for follow-up visits, undergo sleep studies (including in-lab and at-home), and complete questionnaires related to the registry; 8. Subject is willing and able to provide informed consent. Exclusion Criteria: 1. Subject has a combination of central + mixed apneas \> 25% of the total apnea-hypopnea index (AHI); 2. Subject has any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate; 3. Subject has any condition or procedure that has compromised neurological control of the upper airway; 4. Subject is unable, or does not have the necessary assistance, to operate the patient remote; 5. Subject is pregnant or plans to become pregnant; 6. Subject has an implantable device that may be susceptible to unintended interaction with the Inspire System; 7. Subject has a terminal illness with life expectancy \< 12 months; 8. Any other reason the investigator deems the subject is unfit for participation in the registry.

Primary outcome measure(s)

Trial sites (8)

FacilityCityRegionStatus
Childrens Hospital of Colorado Aurora Colorado Recruiting
Children's Healthcare of Atlanta Atlanta Georgia Terminated
Duke University Durham North Carolina Recruiting
Cincinnati Childrens Hospital Cincinnati Ohio Recruiting
Children's Hospital of Philadelphia Philadelphia Pennsylvania Recruiting
Children's Hospital of Pittsburgh Sewickley Pennsylvania Recruiting
University of Texas Southwestern/Children's Hospital of Dallas Dallas Texas Recruiting
Children's Hospital of the King's Daughters/East Virginia Medical School Norfolk Virginia Recruiting

More Inspire Medical Systems, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04457154 on ClinicalTrials.gov ↗ ← All trials in the USA